Disposalbe air/water and suction valves for an endoscope

ABSTRACT

A disposable air/water valve for an endoscope, including a shaft having a passage from an opening to a vent. The shaft has grooves and ridges and a protrusion formed at the vent. Seals are set within some of the grooves. An inner ring, having a diaphragm, extends from an outer circumference of the inner ring to an internal circumference of an outer cap. Hinges extend vertically downward from the diaphragm and ribs are formed along the internal circumference of the outer cap. A button cap has an internal ring that securely attaches to the shaft. A resilient member is securely disposed between the button cap and the diaphragm. The outer cap, inner ring, and internal ring of the button cap define a central bore to accommodate the shaft therein.

CROSS-REFERENCE

The present specification relies on, for priority, U.S. PatentProvisional Application No. 62/259,573, entitled “Disposable Air/Waterand Suction Valves for An Endoscope”, and filed on Nov. 24, 2015.

In addition, the present specification relies on, for priority, U.S.Patent Provisional Application No. 62/375,359, entitled “DisposableAir/Water and Suction Valves for An Endoscope”, and filed on Aug. 15,2016.

The above-mentioned applications are herein incorporated by reference intheir entirety.

FIELD

The present specification relates generally to endoscopy systems andmore particularly, to disposable air/water and suction valves for usewith an endoscope.

BACKGROUND

Endoscopes have attained great acceptance within the medical communitysince they provide a means for performing procedures with minimalpatient trauma while enabling the physician to view the internal anatomyof the patient. Over the years, numerous endoscopes have been developedand categorized according to specific applications, such as cystoscopy,colonoscopy, laparoscopy, and upper GI endoscopy and others. Endoscopesmay be inserted into the body's natural orifices or through an incisionin the skin.

An endoscope usually includes an elongated tubular shaft, rigid orflexible, having a video camera or a fiber optic lens assembly at itsdistal end. The shaft is connected to a handle which sometimes includesan ocular element for direct viewing. Viewing may also be possible viaan external screen. Various surgical tools may be inserted through aworking channel in the endoscope for performing different surgicalprocedures. Often, the endoscope also has fluid injectors (“jet”) forcleaning a body cavity, such as the colon, into which they are inserted.A control section of the endoscope may include a suction cylinder and anair/water cylinder. Valves may be inserted into these cylinders tocontrol various functions of the endoscope.

For example, an air/water valve for an endoscope may be inserted intothe air/water cylinder or channel of the endoscope to provide air andwater to the endoscope. When the air/water valve is in a first, normalposition, air escapes from a vent in the valve. When insufflation isdesired, an operator places a finger over the vent, which redirects theair towards the distal end of the endoscope, thus insufflating the organthat is being examined. When the operator engages the air/water valve(e.g. by depressing the valve), air is redirected to a water bottle andcreates pressure in the bottle that causes water to flow towards thedistal end of the endoscope.

In addition, a suction valve for the endoscope may be inserted into thesuction cylinder or channel of the endoscope to provide suction to theendoscope. When the suction valve is in a first, normal position, airflow from the distal tip of the endoscope is blocked by the valve. Whensuction is desired, an operator engages the suction valve (e.g. bydepressing the valve) to open the suction channel to create negativepressure that draws air or fluid into the opening of the instrumentchannel of the endoscope. When the operator releases the suction valve,the valve returns to its normal position blocking air flow and stops thesuctioning.

After each use, an endoscope must be cleaned, disinfected, andsterilized to prevent the spread of disease, germs, bacteria andillness. Many components of an endoscope may be reusable, such as theair/water valve and suction valve and thus, must also be cleaned,disinfected, and/or sterilized between uses. Unfortunately, there isusually a great expense associated with maintaining sterility of theequipment. In addition, since reusable air/water and suction valves maybe assembled from a combination of several metal, plastic, and/or rubbercomponents there are significant costs associated with the manufacturingof reusable air/water valves.

Accordingly, there is a need for single-use or disposable air/water andsuction valves that can be easily manufactured and assembled using avariety of materials for various components of the valves. Additionally,disposable air/water and suction valves do not require expensivematerials to fabricate the valves, thereby eliminating the high cost ofmanufacturing suction valves from expensive materials.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, not limiting in scope. Thepresent application discloses numerous embodiments.

The present specification discloses a disposable air and water valve foran endoscope, comprising: a shaft having a passage from a first openingto a vent, wherein the shaft has at least one groove, at least oneridge, and at least one protrusion formed at the vent; at least one sealset within the at least one groove; an outer cap; an inner ring having adiaphragm that extends from an outer circumference of the inner ring toan internal circumference of the outer cap, wherein at least one hingeextends vertically downwards from said diaphragm and wherein at leastone rib is positioned along the internal circumference of the outer cap;a button cap having an internal ring that securely attaches to the shaftby fitting into a notch near the vent of the shaft; and a resilientmember securely disposed between the button cap and the diaphragm,wherein the outer cap, inner ring, and internal ring of the button capdefine a central bore to accommodate said shaft.

Optionally, the disposable air/water valve further comprises at leastone bushing set within the at least one groove or a second groove,wherein said at least one bushing is configured to center said valvewithin a channel of an endoscope.

The shaft, seals, outer cap, inner ring, and button cap may comprise atleast one of polyurethane, polyurea, polyether(amide), PEBA,thermoplastic elastomeric olefin, copolyester, styrenic thermoplasticelastomer, carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO, rubber, plastic, polycarbonate,ABS, MABS, and silicone.

The resilient member may comprise at least one of a corrosion resistantmetal, polyurethane, polyurea, polyether(amide), PEBA, thermoplasticelastomeric olefin, copolyester, and styrenic thermoplastic elastomer,carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO, rubber, and plastic.

Optionally, the shaft comprises machined steel and said button capcomprises plastic and said shaft is mechanically bonded to said buttoncap.

Optionally, the at least one hinge comprises a tine and barb wherein thebarb has a width of less than 200 microns.

Optionally, the at least one hinge is configured to connect to acorresponding mount on an endoscope and prevent vertical displacement ofsaid at least one seal. Optionally, said at least one hinge isconfigured to generate an audible and tactile snap when said at leastone hinge is connected to said corresponding mount, thereby indicatingthat the valve has been seated correctly.

Optionally, the at least one rib is configured to act as an edge stop toensure said valve is centered on the mount and prevent a side loadingfrom breaking said at least one seal.

Optionally, the outer cap and said inner ring with said at least onehinge and said at least one rib are molded as a single component.

The present specification also discloses a disposable suction valve foran endoscope, comprising: a shaft having a passage from a first openingto a vent, wherein the shaft has a plurality of grooves, a plurality ofridges and a protrusion formed at the vent; an outer cap; an inner ringhaving a diaphragm that extends from an outer circumference of the innerring to an internal circumference of the outer cap, wherein a pluralityof vertical hinges extend downward from said diaphragm and wherein aplurality of vertical ribs are formed along the internal circumferenceof the outer cap; a button cap having an internal ring configured tosecurely attach to the shaft; and a resilient member securely disposedbetween the button cap and the diaphragm, wherein the outer cap, innerring, and internal ring of the button cap define a central bore toaccommodate the shaft.

Optionally, the internal ring securely attaches to the shaft by fittinginto a tapered notch near the vent of the shaft.

Optionally, each of the plurality of hinges comprises a tine and a barb.Optionally, the barb is defined by a width of less than 200 microns.

Optionally, said plurality of hinges is configured to connect to acorresponding mount on an endoscope. Optionally, each of said pluralityof hinges is configured to generate an audible and tactile snap wheneach of said plurality of hinges connects to said corresponding mount.

Optionally, each of said plurality of vertical ribs is configured to actas an edge stop to ensure said valve is centered on the mount.

Optionally, the outer cap and said inner ring with said plurality ofhinges and said plurality of ribs are molded as a single component.

The present specification also discloses a method of operating adisposable air/water valve for an endoscope comprising an air channeland a water channel each connected to a water bottle, said methodcomprising: placing a disposable air and water valve in a port of anendoscope wherein said disposable air and water valve comprises: a shafthaving a passage from a first opening to a vent, wherein the shaft has aplurality of grooves, a plurality of ridges, and a protrusion formed atthe vent; a plurality of seals set within at least a portion of theplurality of grooves; an outer cap; an inner ring having a diaphragmthat extends from an outer circumference of the inner ring to aninternal circumference of the outer cap, wherein a plurality of hingesextend vertically downwards from said diaphragm and wherein a pluralityof ribs are formed along the internal circumference of the outer cap; abutton cap having an internal ring configured to securely attach to theshaft; and a member securely disposed between the button cap and thediaphragm, wherein the outer cap, inner ring, and internal ring of thebutton cap define a central bore to accommodate the shaft; allowing airto enter at said first opening and escape from said vent when valve isun-actuated; covering said vent to force air through said air channel ina distal direction to insufflate a body cavity; actuating said valve bydepressing said button cap to compress said resilient member and movesaid first opening into said water channel, forcing air into said waterbottle and resulting in water being forced through said water channel ina distal direction; and releasing said button cap to allow saidresilient member to decompress, move said first opening out of alignmentwith said water channel, un-actuate said valve and stop said flow ofwater.

The present specification also discloses a method of operating adisposable suction valve for an endoscope connected to a suction pump,said method comprising: placing a disposable suction valve in a suctioncylinder of an endoscope wherein said disposable suction valvecomprises: a shaft having a passage from a first opening to a vent,wherein the shaft has a plurality of grooves, a plurality of ridges anda protrusion formed at the vent; an inner ring having a diaphragm thatextends from an outer circumference of the inner ring, wherein at leastone hinge extends downward from said diaphragm; a button cap with aninternal ring configured to securely attach to the shaft; and aresilient member securely disposed between the button cap and thediaphragm; preventing the suction pump from preventing negative pressurein the suction channel by not actuating said suction valve; actuatingsaid suction valve by depressing said button cap to compress saidresilient member and move said first opening into alignment with saidsuction channel, allowing said suction pump to create negative pressurein said suction channel to suction air and/or fluid from a distal end ofsaid endoscope; and releasing said button cap to allow said resilientmember to decompress to thereby move said first opening out of alignmentwith said suction channel, un-actuate said valve and stop said suction.

The aforementioned and other embodiments of the present shall bedescribed in greater depth in the drawings and detailed descriptionprovided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will beappreciated, as they become better understood by reference to thefollowing detailed description when considered in connection with theaccompanying drawings, wherein:

FIG. 1A is a perspective view of a single use, disposable air/watervalve in accordance with an embodiment of the present specification;

FIG. 1B is a cross-section view of the air/water valve of FIG. 1A;

FIG. 1C is another cross-section view of the air/water valve of FIG. 1A;

FIG. 1D is yet another cross-section view of the air/water valve of FIG.1A;

FIG. 1E is a bottom perspective view of the air/water valve of FIG. 1A;

FIG. 1F is a bottom view of the air/water valve of FIG. 1A;

FIG. 1G illustrates a first hinge or hook configured to enable a firstamount of insertion/removal force, in accordance with an embodiment;

FIG. 1H illustrates a second hinge or hook configured to enable a secondamount of insertion/removal force, in accordance with an embodiment;

FIG. 1I illustrates a third hinge or hook configured to enable a thirdamount of insertion/removal force, in accordance with an embodiment;

FIG. 1J illustrates a fourth hinge or hook configured to enable a fourthamount of insertion/removal force, in accordance with an embodiment;

FIG. 2A is a table showing an air/water valve insertion force for a 140micron hook;

FIG. 2B is a table showing an air/water valve insertion force for a 70micron hook;

FIG. 2C is a table showing an air/water valve insertion force for a 35micron hook;

FIG. 2D is a table showing an air/water valve removal force for a 140micron hook;

FIG. 2E is a table showing an air/water valve removal force for a 70micron hook;

FIG. 2F is a table showing an air/water valve removal force for a 35micron hook;

FIG. 3A is an illustration showing various dimensions of a 70 micronhook that is used in an air/water valve of the present specification;

FIG. 3B is an illustration showing various dimensions of a 70 micronhook that is used in an air/water valve of the present specification;

FIG. 3C is an illustration showing various dimensions of a 70 micronhook that is used in an air/water valve of the present specification;

FIG. 3D is a table showing an air/water valve depression force for a 140micron hook;

FIG. 3E is a table showing an air/water valve depression force for a 70micron hook;

FIG. 3F is a table showing an air/water valve depression force for a 35micron hook;

FIG. 4A illustrates an embodiment of an exemplary outer cap with a hooksize of 70 micros and a lead-in angle of 15 degrees on each side;

FIG. 4B shows a bottom view (or attachment portion) of the outer cap ofFIG. 4A that is used to attach the air/water valve to a correspondingmount of an endoscope;

FIG. 4C is a diagram showing the location of cross-section A-A of anouter cap;

FIG. 4D is a cross-sectional view of the outer cap of FIG. 4C;

FIG. 4E is a diagram showing the location of cross-section A-A on anouter cap;

FIG. 4F is a cross-sectional view of the outer cap of FIG. 4E; and

FIG. 4G which represents an exploded view of cross section B-B of FIG.4F.

FIG. 5 is a flow chart illustrating a plurality of exemplary stepsinvolved in operating an air/water valve of the present specification;

FIG. 6A is a perspective view of a disposable suction valve inaccordance with an embodiment of the present specification;

FIG. 6B is a top view of the disposable suction valve of FIG. 6A; FIG.6C is a vertical cross-section view along an axis F-F of the disposablesuction valve of FIG. 6A;

FIG. 6D is a horizontal cross-section view along an axis G-G of thedisposable suction valve of FIG. 6C;

FIG. 6E is a bottom perspective view of the disposable suction valve ofFIG. 6A;

FIG. 6F is a magnified view of the bottom of the disposable suctionvalve of FIG. 62E; and,

FIG. 7 is a flow chart illustrating a plurality of exemplary stepsinvolved in operating a suction valve of the present specification;

DETAILED DESCRIPTION

The present specification is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention. In the description and claims of theapplication, each of the words “comprise” “include” and “have”, andforms thereof, are not necessarily limited to members in a list withwhich the words may be associated.

It should be noted herein that any feature or component described inassociation with a specific embodiment may be used and implemented withany other embodiment unless clearly indicated otherwise.

As used herein, the indefinite articles “a” and “an” mean “at least one”or “one or more” unless the context clearly dictates otherwise.

It is noted that the term “endoscope” as mentioned to herein may referparticularly to colonoscopes and gastroscopes, according to someembodiments, but is not limited only to colonoscopes and gastroscopes.The term “endoscope” may refer to any instrument used to examine theinterior of a hollow organ or cavity of the body.

FIG. 1A is a perspective view of a disposable air/water valve 100 inaccordance with an embodiment of the present specification while FIGS.1B, 1C and 1D are respectively first, second and third cross-sectionviews of the air/water valve 100. Referring now to FIGS. 1A through 1D,the air/water valve 100 comprises a stem or shaft 105 having a pluralityof grooves 109, 110, 111, 112, 113, 114, 115 and ridges 116, 117, 118,119, 120, 121, 122, 123 that are molded or machined, in variousembodiments, as part of the shaft 105. A plurality of seals 125, 127,and 129 may be set into the respective grooves 109, 112, 114 inaccordance with some embodiments. A plurality of bushings 126, 128 maybe set into respective grooves 110, 113 in accordance with someembodiments. The bushings 126, 128 assist in centering the air/watervalve 100 in a channel within an endoscope. In various embodiments, thebushings 126, 128 are rigid or semi-rigid. In some embodiments, theair/water valve includes two bushings 126, 128 positioned in grooves110, 113 respectively. In other embodiments, the air/water valve 100includes only bushing 126 positioned in groove 110. In otherembodiments, the device does not have bushings and, instead, rely onribs to center the valve appropriately. In addition, air/water valve 100may also comprise inner ring 135, outer cap 140, resilient member 145(FIG. 1C, 1D) such as, but not limited to, spring, rubber, elastic, anda button cap 150.

In accordance with aspects of the present specification, the ridge 116prevents unintentional removal of the seal 125 by providing anadditional interference between the seal 125 and the shaft 105. Invarious embodiments, the shaft 105 has a preferred travel direction(from the ridge 116 toward the end 165) which enables an easierplacement of the seal 125 than removal of the seal due to a direction oftaper of the ridge 116.

The components of air/water valve 100 may comprise at least onedisposable material, including, but not limited to polyurethane,polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin,copolyester, styrenic thermoplastic elastomer, carbon fiber, glassfiber, ceramics, methacrylates, poly (N-isopropylacrylamide),PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS,MABS, silicone, or combinations thereof. The resilient member 145 may beformed from a suitable material, such as corrosion resistant metal,polyurethane, polyurea, polyether(amide), PEBA, thermoplasticelastomeric olefin, copolyester, and styrenic thermoplastic elastomer,carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic, orcombinations thereof.

It should be understood that the plurality of seals 125, 127, and 129can be any member suitable for sealing a portion of the shaft 105. Thepositioning of the seals corresponds to the water and air channels. Theseals serve to prevent air from entering the water channel and toprevent air from exiting anywhere other than outside of the vent hold onthe top of the shaft 105. In some embodiments, the plurality of sealscan be permanently attached to the shaft 105, such as for example, byover-molding. In other embodiments, the plurality of seals can beremovably attached to the shaft 105, such as for example, by sliding theseal onto shaft 105. Like other components of the air/water valve 100,the plurality of seals can comprise polyurethane, polyurea,polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester,and styrenic thermoplastic elastomer, carbon fiber, glass fiber,ceramics, methacrylates, poly (N-isopropylacrylamide), PEO-PPO-PEO(pluronics), rubber, plastic (e.g., polycarbonates), ABS, MABS, siliconeor combinations thereof.

In embodiments, the air/water valve 100, when attached to or mountedonto an endoscope enables an air-flow rate of at least 800 cc/min fromthe tip section of the endoscope, wherein the tip section is capable ofan overall output of about 1500 cc/min at a pressure of 0.05 MPa (megapascal). In some embodiments, the seal 127 is fabricated from a TPE(Thermoplastic Elastomer) material having a wall thickness of 0.35 mmand a 50 shore A hardness which enables an air-flow rate of at least 800cc/min. In a preferred embodiment, the seal 127 is fabricated from a TPEmaterial having a wall thickness of 0.22 mm and a 50 shore A hardnesswhich enables an air-flow rate in a range of 1250 to 1300 cc/min. Itshould be appreciated that the wall thickness for the seal 127 may vary,in other embodiments, depending upon at least the type of material,hardness, geometry, molding conditions and number of support ribs. Insome embodiments, the seal 127 includes, along its sides, a plurality ofribs. One embodiment of the seal 127 comprises four ribs 90 degreesapart from one another—two fully spanning the cross-section of the sealand the other two acting as filling channels. In one embodiment, theair-flow rate is a minimum of 700 cc per minute.

The shaft 105 provides an opening 155 and a passage or bore 160 thatruns upwards through the shaft 105, substantially along a longitudinalaxis 170, from the opening 155 to an end or vent 165. The opening 155lies along an axis 172 that is substantially perpendicular to thelongitudinal axis 170. When the end or vent 165 is not covered by anoperator, air may travel via the opening 155 and up the passage or bore160 to escape from the vent 165.

The inner ring 135 has a diaphragm or collar 136 extending from an outercircumference of the inner ring 135 to the internal circumference of theouter cap 140. The resilient member 145 is installed to lie between theinner ring 135 and the button cap 150 such that one end of the resilientmember 145 is secured to the diaphragm or collar 136 and the other endto the button cap 150. In some embodiments, the inner ring 135 is amonolithic internally molded part of the outer cap 140 while in otherembodiments these may be two separate components. In variousembodiments, the outer cap 140 (along with the inner ring 135 whenmolded as a monolithic part of the outer cap 140) is molded usingmaterial of sufficient rigidity. In an embodiment, the outer cap 140 ismolded from ABS having a Rockwell R hardness of 112 or hardness in therange of 70 to 90 shore D. The inner ring 135, outer cap 140 and thebutton cap 150 respectively define internal bores for receiving the endor vent 165 of the shaft 105. End 165 of the shaft 105 is placed throughinner ring 135 and resilient member 145 and secured to the button cap150 (as shown in FIGS. 1C, 1D). When assembled, the diaphragm or collar136 of the inner ring 135 rests upon the ridge 123.

In accordance with an aspect of the present specification and as shownin FIG. 1D, an internal ring 180 of the button cap 150 is secured to theshaft 105, at the end 165, within a tapered notch, groove or recessedportion 175 (on the outer diameter of the shaft 105) defined between adetent or protrusion 178 (towards the end 165) and a ridge 179. In anembodiment, the notch portion 175 is tapered at an angle ‘A’ withreference to a vertical line parallel to the longitudinal axis 170.

Conventional valves typically use adhesive or welded joints to join orsecure the button cap to the shaft. However, the securing mechanism ofthe present specification allows the use of dissimilar materials for thecomponents such as the button cap 150 and the shaft 105. For example,the shaft 105 may be of metal while the button cap 150 may be of plasticor the shaft 105 and the button cap 150 may both be of plastic yet ofdifferent melt temperatures. During a sterilization process, such asautoclaving, the plastic button cap 150 will melt and then becomesecured to shaft 105 as it dries post sterilization. Using dissimilarmaterial for the button cap 150 and shaft 105 eliminates the need ofmatching material properties required in a gluing or welding process.Typically, materials must be selected so that they have similar melttemperatures (in the case of welding) or have surface propertiesconducive to adhesives. Eliminating such constraints allows theindividual component materials of the button cap 150 and shaft 105 to beoptimized for their specific purposes. For example, in some embodiments,the button cap is molded out of a lubricious plastic (ABS, Acetal, PTFE)that is cheap to manufacture. In some embodiments, the shaft 105 ismachined out of steel and mechanically bonded to a plastic button. Useof a machined steel shaft allows for dimensional and geometrictolerances (diameter, straightness) that are difficult or impossible tomeet with conventional molding. The shaft 105 and the button cap 150,though manufactured of different materials or materials of differentproperties may be easily secured using the securing mechanism of thepresent specification. This further allows for optimization of materialsfor the shaft 105 and the button cap 150 and therefore the fabrication,manufacturing and assembly processes.

In accordance with another aspect of the present specification and asshown in FIGS. 1C, 1E and 1F, a plurality of hinges or hooks 182 extendvertically downwards (substantially parallel to the longitudinal axis170) from the diaphragm or collar 136. The plurality of hinges 182enables attachment of the air/water valve 100 to a corresponding mountof an endoscope. In various embodiments, the corresponding mount of anendoscope comprises a flange which is surrounded by ribs 185 of theouter cap 140, as described further below, and onto which the hinges 182of the outer cap 140 snap and connect. Thus, ribs 185 and hinges 182contained within outer cap 140 are used to connect the air/water valveto the flange of an endoscope. In various embodiments, the flange is anintegral part of the endoscope and not single use or disposable. Use ofthe hinges 182 for attachment prevents vertical displacement of theseals and provides an audible and tactile positive locking ‘snap’indicating to a user that the valve 100 is properly seated.Conventionally, over-molded TPE/TPU/Silicone in a two-part design isused for attaching the valve to the endoscope mount. However, theattachment mechanism enabled by the plurality of hinges 182 of thepresent specification is easier to manufacture while also providing amore secure connection to the endoscope during use. Specifically,inclusion of the hinges 182 reduces the overall part count. A singlecomponent is molded for the device of the present specification,whereas, in the prior art, a two-step molding process must be used ormanual assembly of a rubber boot with a rigid plastic collar isrequired. A single mold results in shorter molding times and lowertooling costs. Elimination of a manual assembly step reduces overalllabor input into the device.

In accordance with aspects of the present specification, it is desirableto configure or design the hinges or hooks 182 so that it achieves botha tactile, locking feel while the valve 100 is attached to the endoscopemount (using the hinges 182) but is not so engaged that removing thevalve 100 (such as for autoclaving, for example) poses a challenge. Inother words, it is desired that the amount of insertion force requiredto engage the hinges or hooks 182 to the endoscope mount should beoptimal that enables sufficient retention or attachment of the valve 100to the endoscope mount without the retention being too strong to enabledetachment of the valve 100 from the endoscope mount a challenge.

FIGS. 1G through 1J, respectively illustrate first, second, third andfourth hinges or hooks 182 g, 182 h, 182 i, 182 j configured inaccordance with various embodiments. In various embodiments, each hingeor hook 182 g ,182 h, 182 i, 182 j respectively comprises a barb 191,192, 193, 194 which is curved or angled (lead-in angle) on at least aportion and a tine 195, 196, 197, 198, which is a straight portion.Together, the barb and tine form an opening that is used to attach thevalve 100 to an endoscope mount 101. In an embodiment, the barb faces aninner diameter of the valve and the tine faces the outer diameter of thevalve. In embodiments, the amount of insertion force required to engagea valve with an endoscope mount, degree of retention of the mountedvalve, amount of depression force required to actuate the mounted valveand the amount of removal force required to disengage the valve from theendoscope mount are determined by at least a width ‘w’ and a lead-inangle Θ of the barb.

In one embodiment, as shown in FIG. 1G, the barb 191 has a widthw_(g)=0.5 mm and a lead-in angle Θ_(g)=45 degrees enabling the hinge orhook 182 g to require a first amount of insertion/removal force.

In another embodiment, as shown in FIG. 1H, the barb 192 has a widthw_(h)=0.25 mm and a compound lead-in angle Θ_(h)=45/15 degrees(different lead-in angles for each side) enabling the hinge or hook 182h to require a second amount of insertion/removal force.

In another embodiment, as shown in FIG. 1I, the barb 193 has a widthw_(i)=0.5 mm and a compound lead-in angle Θ_(i)=45/15 degrees (differentlead-in angles for each side) enabling the hinge or hook 182 i torequire a third amount of insertion/removal force.

In yet another embodiment, as shown in FIG. 1J, the barb 194 has a widthw_(j)=0.5 mm and a lead-in angle Θ_(j)=15 degrees enabling the hinge orhook 182 j to require a fourth amount of insertion/removal force.

The amount of insertion/removal force corresponding to the hinges orhooks 182 g through 182 j varies as follows: first insertion/removalforce>second insertion/removal force>third insertion/removalforce>fourth insertion/removal force. Accordingly, the correspondingretention is highest for hinge or hook 182 g progressively reducing forhinges or hooks 182 h, 182 i and lowest for hinge or hook 182 j.Therefore, it can be generalized that the greater the width and thegreater the compound lead-in angle, the greater the amount of forceneeded for insertion/removal.

As an example, air/water valve hinges or hooks having barb dimensions of140 microns, 70 microns and 35 microns were tested to determineinsertion force, removal force, and depression force. Note that a unithaving 0 microns (or no barb) would have a very low retention force thatwould be insufficient for the purposes of the present invention. Asshown in the table 205 in FIG. 2A, for the 140 micron hooks, theinsertion force varied from 8.1 to 12.2 N. As shown in table 210 in FIG.2B, for the 70 micron hooks, the insertion force varied from 7.4 to 13N.As shown in table 215 in FIG. 2B, for the 35 micron hooks, the insertionforce varied from 6.4 to 12N. While there is some overlap, the generaltrend shows that the thinner the barb, the less the insertion forcerequired.

As shown in the table 220 in FIG. 2D, for the 140 micron hooks, theremoval force varied from 5.8 to 14.2 N. As shown in the table 225 inFIG. 2E, for the 70 micron hooks, the removal force varied from 4.0 to9.2 N. As shown in the table 230 in FIG. 2F, for the 35 micron hooks,the removal force varied from 4.5 to 6.6 N. Again, while there is someoverlap, the general trend shows that the thinner the barb, the less theremoval force required.

FIGS. 3A, 3B and 3C are partial diagrams of a molded and machinedair/water outer cap 300. In an embodiment, as shown in FIG. 3A, anexemplary molded hook portion 320 has a width 321 of approximately 2.10mm. Further, as shown in FIG. 3B, the thickness 322 of the hook 320 at abase portion 323 is approximately 0.7 mm. In an embodiment, it should benoted that the thickness 322 of the base portion 323 of the hook 320ranges from 0.5 mm to 1.0 mm, as too thick of a hook will lead tostiffness and too thin of a hook will lead to a part that is notmoldable.

As shown in FIG. 3C, the overall length or height 324 of the hook 320 isapproximately 3.8 mm. Further, hook 320 travels a distance 325 of 0.504mm when depressed or engaged. As shown in the table 314 in FIG. 3D, forthe 140 micron hooks, the depression force varied from 9.15 to 20.95 N.As shown in the table 316 in FIG. 3E, for the 70 micron hooks, thedepression force varied from 9.40 to 18.94 N. As shown in the table 318in FIG. 3F, for the 35 micron hooks, the depression force varied from10.65 to 15.26 N. Again, while there is some overlap, the general trendshows that the thinner the barb, the less the depression force required.

In one embodiment, the hook, having a barb and tine, comprises a barbhaving a width of less than 200 micron.

In accordance with still another aspect of the present specification andas shown in FIGS. 1E and 1F, a plurality of positioning ribs 185 areformed along the inner circumference of the outer cap 140. The ribs 185extend vertically downwards (substantially parallel to the longitudinalaxis 170) along the inner circumference of the outer cap 140. The ribs185 enable the valve 100 to be centered on a valve well on theendoscope, aligning the shaft 105 with a center of the valve well andenabling precise vertical positioning of the plurality of seals withinthe valve well. The ribs 185 act as edge stops to ensure the valve 100is centered on the mount and also prevent side loading from the userfrom breaking the seals on the valves.

In various embodiments, the shaft 105 of the disposable air/water valve100 along with the plurality of ridges and grooves are of the samematerial as the shaft 105. Similarly, the plurality of hinges or hooks182 and ribs 185 may be molded as components of the inner ring 135 andthe outer cap 140 (the inner ring 135 and outer cap 140 may also bemolded as a single component) in accordance with various embodiments. Itshould be appreciated that the shaft 105, the plurality of seals 125,127, and 129, inner ring 135, outer cap 140 and button cap 150 may allbe manufactured from dissimilar materials and still be easily assembledor secured together in accordance with various aspects of the presentspecification.

As described with respect to FIGS. 1C, 1E and 1F, a plurality of hingesor hooks 182 extend vertically downwards (substantially parallel to thelongitudinal axis 170) from the diaphragm or collar 136. The pluralityof hinges or hooks 182 enables attachment of the air/water valve 100 toa corresponding mount of an endoscope. FIGS. 4A, 4B, 4C, 4D, 4E, 4F, and4G illustrate an exemplary outer cap and associated components having abarb hook size of 70 microns with a lead-in angle of 15 degrees on eachside. Outer cap 500 is shown in FIG. 4A and in an embodiment, has aheight ‘h’ of approximately 12.20 mm. FIG. 4B shows the underside 405 orattachment portion of outer cap 400 that is used to attach the air/watervalve to a corresponding mount of an endoscope. As shown in FIG. 4B, theattachment portion 405 may have a diameter of approximately 18.33 mm.FIG. 4C is a diagram showing the cross-section A-A 410 of outer cap 400which is described in greater detail in FIG. 4D. As shown in FIG. 4D,cross section A-A 410 of the outer cap 400 shows an approximate distance415 a of 13.30 mm between hooks 420, at a proximal end 420 a, at thebarbs 430 where the hook engages with a flange on the correspondingmount of an endoscope. At a distal end 420 b, the approximate distance415 b between hooks 420 is 14.50 mm. Further, the approximate length 425of each hook 420 is 4.10 mm.

FIG. 4E shows outer cap 400 with cross-section A-A 450 in a differentview, as represented by FIG. 4F. As shown in FIG. 4F, the approximatedistance 455 between barbs 430 of the hook 420 (where the hook engageswith a flange on the corresponding mount of an endoscope) is 14.185±0.06mm. In one embodiment, the barbs 430 are machined at an angle 435 ofapproximately 15±3 degrees with respect to a central longitudinal axis460. Further, a straight edge of barbs 430, located just above theangular slanted portion, is machined at a distance of approximately7.530 mm from the central longitudinal axis 460. This detail is shown inFIG. 4G which represents an exploded view of cross section B-B of FIG.4F. Further, a straight portion or tine 440 of hook 420 extendsapproximately 0.320±0.1 farther than barbs 430.

FIG. 5 is a flow chart illustrating a plurality of exemplary stepsinvolved in operating an air /water valve of the present specification.Referring now to FIGS. 1A through 1D and FIG. 5, during operation theair/water valve 100 of the present specification may be positioned in anair/water cylinder of an endoscope. The endoscope provides an airchannel for air and a water channel for water. The air and waterchannels are connected to a water bottle. The water channel extends intothe fluid contained in the water bottle. When air/water valve 100 isplaced in the air/water cylinder of the endoscope, the air/water valve100 passes through both the air and water channels.

At step 505, the air/water valve 100 is un-actuated, that is the buttoncap 150 is not depressed and the resilient member 145 is not compressed,and the vent 165 is open. As a result, at step 510 the air/water valve100 allows air flow (provided by an air pump, for example) to enter thevalve opening 155 and escape from the vent 165. Note that disposableair/water valve 100 provides a plurality of seals (125, 127, and 129)that prevent air or water from leaking from the air or water channels.Also, the opening 155 of the air-water valve 100 is not aligned with thewater channel and therefore there is no movement of water away from thewater bottle, as the water channel is blocked.

At step 515, the air/water valve 100 is unactuated, that is the buttoncap 150 is not depressed and the resilient member 145 is not compressed,but the vent 165 is closed or covered by an operator (using his finger,for example). As before, from the previous step 510, the water channelis still blocked by the air/water valve 100. Since the air vent 165 isnow blocked by the operator, air from the air pump flows, at step 520,past the air/water valve 100 towards a distal end of an endoscope. Thisallows the operator to insufflate a body cavity by blocking the air vent165 of air/water valve 100 without actuating the valve.

At step 525, the air/water valve 100 is actuated, that is the button cap150 is depressed and the resilient member 145 is compressed, and thevent 165 continues to remain obstructed, closed or covered by theoperator. Depressing the button cap 150 causes a downward force to beapplied to the shaft 105 via ridge 179 and therefore the shaft 105 movesor is displaced downwards. Also, depressing the button cap 150 causesthe resilient member 145 to compress against the supporting collar ordiaphragm 136.

The collar 136 rests against the endoscope mount and is thereforeprevented from moving downwards (due to the depression of the button cap150). The downward movement or displacement of the shaft 105 causes thevalve 100 to block the air channel and moves the opening 155 into thewater channel, thereby creating a passageway for water to pass throughthe air/water valve 100, at step 530. Because the vent 165 is alsoblocked by the operator pressing down on the valve 100 (for depressingthe button cap 150), air flows instead into the water bottle via an airbranched-channel connected to the water bottle. As the air pressure inwater bottle increases, fluid is forced from the water bottle into thewater channel, at step 535. Thus, by actuating the air/water valve 100,the operator causes water to flow towards the distal end of theendoscope for rinsing or irrigation.

When the operator stops depressing the button cap 150, the compressedresilient member 145 begins to recoil or get uncompressed. The recoilingresilient member 145 applies an upward force to the button cap 150 thatin turn transfers the upward force to the shaft 105 via the detent orprotrusion 178. This causes both the shaft 105 and the button cap 150 tobe displaced upwards and return to the un-actuated position of the valve100 of step 505.

FIG. 6A is a perspective view of a disposable suction valve 600 inaccordance with an embodiment of the present specification, FIG. 6B is atop view of the disposable suction valve 600, FIG. 6C is a verticalcross-section view along an axis F-F of the disposable suction valve 600of FIG. 6A while FIG. 6D is a horizontal cross-section view along anaxis G-G of the disposable suction valve 600 of FIG. 6C. Referring nowto FIGS. 6A through 6D, the disposable suction valve 600 comprises astem or shaft 605 of outer diameter ‘D’ and having a first groove orrecess 610 (of a first diameter d₁ ) and a second groove or recess 612(of a second diameter d₂) formed on the outer circumference of the shaft605 and towards an end 615 of the shaft 605; the first and secondgrooves 610, 612 result in the formation of a first ridge 611 and asecond ridge 613; an inner ring 620 having a bore of a first internaldiameter b₁ along a first length l₁ (parallel to the longitudinal axisF-F) of the bore and a second internal diameter b₂ along a second lengthl₂ (parallel to the longitudinal axis F-F) of the bore, wherein b₁ isapproximately equal to d₂ and b₂ is approximately equal to ‘D’; an outercap 630; a resilient member 635 such as, but not limited to, spring,rubber, elastic; and a button cap 640 having a central bore (along thelongitudinal axis F-F).

The components of the disposable suction valve 600 may comprisedisposable material, including, but not limited to polyurethane,polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin,copolyester, styrenic thermoplastic elastomer, carbon fiber, glassfiber, ceramics, methacrylates, poly (N-isopropylacrylamide),PEO-PPO-PEO (pluronics), rubber, plastic (e.g., polycarbonates), ABS,MABS, silicone, or combinations thereof. The resilient member 635 may beformed from a suitable material, such as corrosion resistant metal,polyurethane, polyurea, polyether(amide), PEBA, thermoplasticelastomeric olefin, copolyester, and styrenic thermoplastic elastomer,carbon fiber, glass fiber, ceramics, methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO (pluronics), rubber, plastic, orcombinations thereof.

The shaft 605 provides an opening 655 and a passage or bore 660 thatruns through the shaft 605, substantially along the longitudinal axisF-F, from the opening 655 and vertically downwards to an end, opening orvent 665. The opening 655 lies along an axis G-G that is substantiallyperpendicular to the longitudinal axis 670. Fluid may pass horizontallythrough one side of the opening 655 and vertically downwards through thevent 665. Opening 655 and vent 665 allow air or fluid to pass through asuction channel of the endoscope when the suction valve 600 is actuated.

The inner ring 620 has a diaphragm or collar 625 (FIG. 6D) extendingfrom an outer circumference of the inner ring 620 to the internalcircumference of the outer cap 630. The resilient member 635 residesbetween the inner ring 620 and the button cap 640 such that one end ofthe resilient member 635 is secured to the diaphragm or collar 625 andthe other end to the button cap 640. In some embodiments, the inner ring620 is a monolithic internally molded part of the outer cap 630 while inother embodiments these may be two separate components. The inner ring620, outer cap 630 and the button cap 640 respectively define internalbores for receiving the end 615 of the shaft 605. End 615 of the shaft605 is placed through inner ring 620 and resilient member 635 andsecured to the button cap 640. When assembled, the first length l₁ ofthe bore of the inner ring 620 fits over the second groove 612 (since,b₁ is approximately equal to d₂) to rest upon the second ridge 613.

In accordance with an aspect of the present specification and as shownin FIG. 6C, an internal ring 680 of the button cap 640 is secured to theshaft 605, at the end 615, within the first groove or recess 610 thathas a taper defined between a detent or protrusion 678 (towards the end615) and the first ridge 611. In an embodiment, the first groove orrecess 610 is tapered at an angle ‘N’ with reference to a vertical lineparallel to the longitudinal axis F-F. Conventional designs typicallyjoin or secure the button cap to the shaft using adhesive or weldedjoints. For optimal performance, the suction valve shaft requires a highdegree of dimensional precision, generally not available to moldedcomponents. The securing mechanism of the present specification allowsfor a higher degree of dimensional precision through the use ofdissimilar materials for the components such as the button cap 640 andthe shaft 605. For example, the shaft 605 may be of metal while thebutton cap 640 may be of plastic or the shaft 605 and the button cap 640may both be of plastic yet of different melt temperatures. During asterilization process, such as autoclaving, the plastic button cap 640will melt and then become secured to shaft 605 as it dries poststerilization. Using dissimilar material for the button cap 640 andshaft 605 eliminates the need of matching material properties requiredin a gluing or welding process. Typically, materials must be selected sothat they have similar melt temperatures (in the case of welding) orhave surface properties conducive to adhesives. Eliminating suchconstraints allows the individual component materials of the button cap640 and shaft 605 to be optimized for their specific purposes. Forexample, in some embodiments, the button cap is molded out of alubricious plastic (ABS, Acetal, PTFE) that is cheap to manufacture. Insome embodiments, the shaft 605 is machined out of steel andmechanically bonded to a plastic button. Use of a machined steel shaftallows for dimensional and geometric tolerances (diameter, straightness)that are difficult or impossible to meet with conventional molding. Theshaft 205 and the button cap 640 though manufactured of differentmaterials or materials of different properties may be easily securedusing the securing mechanism of the present specification. This furtherallows optimization of materials for the shaft 605 and the button cap640 and therefore their manufacturing and assembling processes.

In accordance with another aspect of the present specification and asshown in FIGS. 6D, 6E and 6F, a plurality of hinges or hooks 682 extendvertically downwards (substantially parallel to the longitudinal axisF-F) from the diaphragm or collar 625. The plurality of hinges or hooks682 enables attachment of the suction valve 600 to a corresponding mountof the endoscope. In various embodiments, the corresponding mount of anendoscope comprises a flange which ribs 685 of the outer cap 630surround, as described further below, and on to which the hinges 682 ofthe outer cap 630 snap and connect. In various embodiments, the flangeis an integral part of the endoscope and not single use or disposable.The hinges or hooks 682 allow the collar component to be a single moldedpart, rather than an over-molded component or an assembly. Use of thehinges or hooks 682, for attachment, provides an audible and tactilepositive locking ‘snap’ indicating to the user that the valve 600 isproperly seated. Typically, a two-part over-molded TPE/TPU/Siliconedesign is used for attaching the valve to the endoscope mount. However,the attachment mechanism enabled by the plurality of hinges 682 of thepresent specification is easier to manufacture while also providing amore secure connection to the endoscope during use. Specifically,inclusion of the hinges 682 reduces the overall part count. A singlecomponent is molded for the device of the present specification,whereas, in the prior art, a two-step molding process must be used ormanual assembly of a rubber boot with a rigid plastic collar isrequired. A single mold results in shorter molding times and lowertooling costs. Elimination of a manual assembly step reduces overalllabor input into the device.

In accordance with still another aspect of the present specification andas shown in FIGS. 6D, 6E and 6F, a plurality of positioning ribs 685 areformed along the inner circumference of the outer cap 630. The ribs 685extend vertically downwards (substantially parallel to the longitudinalaxis F-F) along the inner circumference of the outer cap 630. The ribs685 enable the valve 600 to be centered on a valve well on theendoscope, aligning the shaft 605 with a center of the valve well. Theribs 685 act as edge stops to ensure the valve 600 is centered on themount.

In various embodiments, the plurality of hinges or hooks 682 and ribs685 may be molded as components of the inner ring 620 and the outer cap630 (the inner ring 620 and outer cap 630 may also be molded as a singlecomponent) in accordance with some embodiments. It should be appreciatedthat the shaft 605, inner ring 620, outer cap 630 and button cap 640 mayall be manufactured from dissimilar materials and still be easilyassembled or secured together in accordance with various aspects of thepresent specification.

FIG. 7 is a flow chart illustrating a plurality of exemplary stepsinvolved in operating a suction valve of the present specification.Referring now to FIGS. 6A through 6F and FIG. 7, during operation thedisposable suction valve 600 of the present specification may be placedinto a suction cylinder of the endoscope. A suction channel of theendoscope is linked to the opening 655 (of the suction valve 600) andleads to a distal end of an endoscope or leads toward the patient. Theendoscope may be connected to a suction pump to create negative pressurein the suction channel when the suction valve 600 is actuated.

At step 705, the suction valve 600 is unactuated, meaning that thebutton cap 640 is not depressed and the resilient member 635 is notcompressed. As a result, at step 710, the opening 655 remains out ofposition with the suction channel of the endoscope, thereby preventingthe suction pump from creating negative pressure in the suction channel(that is, no suction is applied to the distal end of the endoscope).

At step 715, the suction valve 600 is actuated—that is, the button cap640 is depressed and the resilient member 635 is compressed. Depressingthe button cap 640 causes a downward force to be applied to the shaft605 via the first ridge 611 and therefore the shaft 605 moves or isdisplaced downwards. Also, depressing the button cap 640 causescompression of the resilient member 635 against the supporting collar ordiaphragm 625. The ring 620 rests against the second ridge 613 as aresult of which the collar 625 is prevented from moving downwards (dueto the depression of the button cap 640). The downward movement ordisplacement of the shaft 605 causes the opening 655 to move intoposition with the suction channel from the distal end of the endoscopeor from the patient. At step 720, by aligning the opening 655 with thesuction channel of the endoscope, a negative pressure created by thesuction pump cause flow from the distal end of the endoscope towards theopening 655 (that is, suction is applied to the distal end of theendoscope). As a result, air and/or fluid may be suctioned from thedistal end of the endoscope when the disposable suction valve 600 is inan actuated position.

When the suction valve 600 is released—that is, button cap 640 is notdepressed the resilient member 635 recoils and applies an upward forceto the button cap 640 that in turn transfers the upward force to theshaft 605 via the detent or protrusion 678. This causes both the shaft605 and the button cap 640 to be displaced upwards and return to theun-actuated position of the valve 600 of step 705.

The above examples are merely illustrative of the many applications ofthe system of present invention. Although only a few embodiments of thepresent invention have been described herein, it should be understoodthat the present invention might be embodied in many other specificforms without departing from the spirit or scope of the invention.Therefore, the present examples and embodiments are to be considered asillustrative and not restrictive, and the invention may be modifiedwithin the scope of the appended claims.

1-20. (canceled)
 21. A valve for a medical device, comprising: a shafthaving a passage from a first opening to a vent; at least one seal; anouter cap; an inner ring having a diaphragm that extends from an outercircumference of the inner ring to an internal circumference of theouter cap, wherein at least one hinge extends vertically downwards fromsaid diaphragm; a button cap attached to the shaft; and a resilientmember disposed between the button cap and the diaphragm, wherein theouter cap, the inner ring, and the button cap define a central bore toaccommodate said shaft; wherein said at least one hinge is configured toconnect to a corresponding mount on the medical device.
 22. The valve ofclaim 21, wherein the shaft further comprises a groove, and the valvefurther comprises a bushing within the groove, wherein the bushing isconfigured to center said valve within a channel of the medical device.23. The valve of claim 21, wherein the shaft, the outer cap, the innerring, and the button cap comprise at least one of polyurethane,polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin,copolyester, styrenic thermoplastic elastomer, carbon fiber, glassfiber, ceramics, methacrylates, poly (N-isopropylacrylamide),PEO-PPO-PEO, rubber, plastic, polycarbonate, ABS, MABS, and silicone.24. The valve of claim 21, wherein the button cap includes an internalring that attaches to the shaft.
 25. The valve of claim 21, wherein theshaft comprises machined steel, the button cap comprises plastic, andthe shaft is mechanically bonded to the button cap.
 26. The valve ofclaim 21, wherein the at least one hinge comprises a tine and barb. 27.The valve of claim 21, wherein the at least one hinge is configured togenerate an audible and/or tactile snap when the at least one hinge isconnected to the corresponding mount, thereby indicating that the valvehas been seated correctly.
 28. The valve of claim 21, wherein at leastone rib is positioned along the internal circumference of the outer cap,and the at least one rib is configured to act as a stop to ensure saidvalve is centered on the mount.
 29. The valve of claim 21, wherein theouter cap and the inner ring with the at least one hinge are molded as asingle component.
 30. The valve of claim 21, wherein said at least onehinge is spaced from the shaft and the outer cap.
 31. The valve of claim21, wherein the at least one hinge is positioned radially-outer relativeto a central longitudinal axis of the shaft from a radially-innermostportion of the inner ring.
 32. The valve of claim 21, wherein the outercap includes a first proximal portion and a second distal portionradially-outer from a central longitudinal axis of the shaft from thefirst proximal portion, wherein the at least one hinge is longitudinallyaligned with the first proximal portion of the outer cap.
 33. A valvefor a medical device, comprising: a shaft having a passage from a firstopening to a vent; an outer cap; an inner ring having a diaphragm thatextends from the inner ring to the outer cap, wherein at least one hingeextends vertically downwards from said diaphragm; a button cap attachedto the shaft; and a resilient member disposed between the button cap andthe diaphragm; wherein said at least one hinge is spaced from the shaft;and wherein said at least one hinge is positioned radially-outerrelative to a central longitudinal axis of the shaft from aradially-innermost portion of the inner ring.
 34. The valve of claim 33,wherein the outer cap includes a first proximal portion and a seconddistal portion radially-outer from a central longitudinal axis of theshaft from the first proximal portion, wherein said at least one hingeis longitudinally aligned with the first proximal portion of the outercap.
 35. The valve of claim 33, wherein the shaft includes a notch, andthe button cap couples to the shaft by fitting in the notch.
 36. Thevalve of claim 35, further comprising a seal within a groove of theshaft.
 37. A valve for a medical device, comprising: a shaft having apassage from a first opening to a vent, the shaft having a longitudinalaxis; an outer cap; an inner ring having a diaphragm that extends fromthe inner ring to the outer cap; a button cap coupled to the shaft; anda resilient member disposed between the button cap and the diaphragm,wherein the outer cap and the inner ring define a central bore toaccommodate said shaft; wherein a portion of the outer cap is radiallyoutward, relative to the longitudinal axis, from a hinge of the outercap, and the hinge is radially outward, relative to the longitudinalaxis, from the inner ring.
 38. The valve of claim 37, wherein at leastone rib is positioned along an internal circumference of the outer cap.39. The valve of claim 37, wherein the button cap is configured toextend within the outer cap when the resilient member is in a compressedposition and in a decompressed position.
 40. The valve of claim 37,wherein an end of the shaft is tapered, and an internal ring of thebutton cap couples to the shaft about the tapered end.